MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TROPONIN T HS; IMMUNOASSAY METHOD, TROPONIN SUBUNIT

Catalog Number 09315357190

Device Problems High Test Results (2457); Low Test Results (2458); Non Reproducible Results (4029)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/20/2023

Event Type  malfunction  

Event Description

The initial reporter stated they received discrepant results for 15 patient samples tested with the elecsys troponin t hs assay on a cobas e 801 analytical unit, serial number (b)(6).Of the data provided the following discrepant results for 5 patient samples are representative examples: on (b)(6) 2023, patient sample 1 initially resulted in troponin t hs value of 17.7 pg/ml and repeated as 83.2 pg/ml.After decantation and centrifugation, the sample was repeated twice, resulting in values of 16.9 pg/ml and 16.7 pg/ml.On (b)(6) 2023, patient sample 2 initially resulted in a troponin t hs value of 62.4 pg/ml.The sample was repeated three times, resulting in values of 50.4 pg/ml, 66.7 pg/ml and 68.1 pg/ml.On (b)(6) 2023, patient sample 3 initially resulted in a troponin t hs value of 47.5 pg/ml and repeated as 54.1 pg/ml on a second cobas analyzer.After decantation and centrifugation, the sample was repeated on the first analyzer resulting in a value of 56.1 pg/ml.On (b)(6) 2023, patient sample 4 initially resulted in a troponin t hs value of 474 pg/ml and repeated as 599 pg/ml.After decantation and centrifugation, the sample was repeated resulting in a value of 507 pg/ml.On (b)(6) 2023, patient sample 5 initially resulted in a troponin t hs value of 390 pg/ml on a second analyzer and repeated as 488 pg/ml on the first cobas analyzer.After decantation and centrifugation, the sample was repeated twice on the first analyzer resulting in values of 507 pg/ml and 508 pg/ml.For samples 1 and 2, no questionable results were reported outside of the laboratory.For samples 3, 4, and 5, it was asked but it is unknown if a questionable result was reported outside of the laboratory.

Manufacturer Narrative

Calibration and quality control results were acceptable.There is no indication of a general instrument or reagent issue.The pre-analytical data show that the number of inversions of the tube and the centrifugation conditions were not adequate.Upon review of the alarm logs, multiple sample clot and sample foam alarms were observed.Camera images collected by the analyzer showed that there was film and particles present, indicating a sample quality issue.The investigation did not identify a product problem.The issue is consistent with a pre-analytical sample handling issue.

• Brand Name: ELECSYS TROPONIN T HS
• Type of Device: IMMUNOASSAY METHOD, TROPONIN SUBUNIT
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 17343959
• MDR Text Key: 319429630
• Report Number: 1823260-2023-02330
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K201441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09315357190
• Device Lot Number: 642405
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2023
• Initial Date FDA Received: 07/18/2023
• Supplement Dates Manufacturer Received: 08/11/2023
• Supplement Dates FDA Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1